鱼腥草注射液临床不合理用药不良事件分析

目的 分析鱼腥草注射液临床不合理用药情况及发生不良事件(adverse event, AE)的风险，为其上市后再评价和临床合理使用提供参考依据。

Analysis of Adverse Events Caused by Irrational Application of Houttuynia Injection

Objective To analyze irrational clinical application of Houttuynia Injection（HI） and the risk of adverse event（AE） occurrence,thus providing references for after-sales reevaluation and rational clinical application of HI.Methods Literatures concerning unreasonable application of HI were searched（terminated by June 2010） from PubMed,EMBASE,Chinese Biomedical Disc（CBMdisc）,Chinese National Knowledge Infrastructure（CNKI）,Chinese Science and Technology Journal Full-text Database（VIP）,and etc.for case report,cross-sectional study,and clinical control study.Results A total of 342 papers with a total of 416 AE cases were retrieved.Of them,AE happened to 294 cases（including 290 children） of the 132 papers concerning contraindications,and 48 with allergic shock;AE happened to 57 cases in 9 papers reporting over-dose,and 6 with high risk combined medication.Sixteen irrational administration ways were reported in 195 papers.Of them,AE happened to 59 cases of seven administration ways（twenty cases by intracavitary injection,thirteen by aerosol inhalation,ten by rinse,eight by oral administration,one by enema,one by acupoint injection,and one by rectal administering）.AE was not reported in the rest ten reports.Conclusion The risk of AE occurrence was increased by changing clinical administration ways of HI without authorization,over-dose medication,high risk combined medication,and application in people with contraindications.